Assoc Dir, CDM

Assoc Dir, CDM

inVentiv Health Clinical SRE, LLC
Not Specified
Not Specified

Job Description

Job Description :
Associate Director, Clinical Data Management
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
. #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job responsibilities
. Ensure project launch, conduct, and closeout activities are performed according to the Customer's and the Company's contractual agreement. Ensures that all program/project-related data management tasks are completed in accordance with internal and customer quality standards, Syneos Health SOPs, and all pertinent industry/regulatory guidelines and legal requirements from commencement to closure of a project. Ensures project documentation is filed on an ongoing basis and the TMF is maintained in an inspection ready state
. Manages multiple projects ranging in and complexity from single service studies, to multiple global projects within a program. Oversees the planning, execution and maintenance of a program of projects.
. At a program level, acts as a Data Management expert to develop data management strategies, identifying and implementing methodologies and technologies to best support projects. Drives continual improvement across a program of projects and effectively shares lessons learnt across projects
. Serves as the sponsor liaison for a program of projects and ensures consistency and continuity amongst the project teams. Represent Clinical Data Management as a member of program governance team / joint operations committee
. Proactively manages the scope, budget, and resource for their assigned projects/program of projects. Manages the financial aspects of the assigned projects, including ensuring projects maintain the correct level of gross profit, and changes in scope are applied as necessary. Ensures that customers are invoiced in a timely manner. Identifies and quantifies resource requirements for ongoing and future projects.
. Point of escalation for individual projects/program of projects. Resolve escalated data management project issues. For key project issues requiring more Senior DM input, propose options for solution to Manager (Senior Department Management) for input and support to resolution
. Ensure effective communication between departments and with Sponsor to ensure a high level of client satisfaction through successful execution of projects.
. Reviews Protocol, Data Management Plan, CRF and Edit Check Specifications to ensure consistency across documentation
. Ensures a review of relevant project Data Management study files for currency and accuracy, including development of a corrective action plan for quality issues or non-compliance.
. Assists in driving recruitment of operational staff. Line Management and functional support of assigned staff. Interview, onboard and train new staff as appropriate. Oversee professional development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching.
. Mentors Project Data Managers in general team leadership skills, project management skills, internal Company processes, and for project specific tasks.
. Manage the resources / workload of assigned team and projects, assigns tasks to team members, manage billable and non-billable time, and subsequently monitors productivity / utilization, timeliness, and quality.
. In collaboration with the Director, ensures effective resource management and maintaining utilization/realization at acceptable levels.
. Supports the Director with Project Review Meetings to ensure that resource, deliverables, scope, quality, and budget are maintained appropriately
. Leads Data Management staff through Sponsor or regulatory audits. Plans for and participates in Sponsor or regulatory audits
. Works with Business Development and the Proposal/Contracts groups to provide input to project budgets and scope of work for customer requested opportunities. Represents Clinical Data Management at Business Development and Sponsor-related meetings
. Perform training for data management staff. Create training materials as required
. Maintains departmental resourcing tracking tools
. Lead or participate in process improvement/departmental strategic initiatives to support the Business. This may include the development of departmental technologies, SOPs, processes and procedures
. Maintains proficiency in Data Management systems and processes through regular training.
. Performs other work-related duties as assigned Qualifications
What we're looking for
. Bachelor's degree, Master's degree preferred, or RN. In lieu of Bachelor's degree or RN, equivalent related education and experience.
. Demonstrated expertise in project management and staff supervision
. Ability to serve in a leadership role in Data Management including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers at all levels
. Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
. Demonstrated experience working within a team matrix structure
. Demonstrated experience in managing multiple priorities in a highly dynamic environment
. Possesses a positive attitude and works well with others
. Knowledge of ICH/GCP regulatory requirements for clinical studies
. Previous line management experience
. Ability to travel as necessary (up to 25%)
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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